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[Are the guidelines guiding us reliable? Evaluation of the Spanish clinical practice guidelines].

BACKGROUND AND OBJECTIVE: There is a large proliferation of clinical practice guidelines (CPG), there being doubts on inconsistencies between the recommendations made and internal incongruencies, that affect the role of the guidelines as instruments helping the clinicians. This study aims to analyze the quality of a group of Spanish CPG and to assess the feasibility of use and consistency of the AGREE Instrument in its Spanish version, designed to evaluate the CPG. METHOD: A total of 278 CPG produced in Spain between January 1990 and December 2002 were identified. The originals of 61 guidelines were recovered from their authors and passed to the AGREE Instrument independently by four raters. Quality of the guidelines feasibility and reproducibility of AGREE were analyzed. RESULTS: For all the attributes of AGREE except in the editorial independence, more than 60% of the guidelines evaluated obtained a poor quality score, there being no domain in which more than 10% of the guidelines was excellent. The worst grading areas are those of applicability, participation and rigour of development of the guidelines. Of the 61 guidelines evaluated, the reviewers graded 25 as "very poor quality", 26 as "non recommendable" and 6 and 4 as "recommendable" or "highly recommendable", respectively. Interrater consistency was high. CONCLUSIONS: The mean quality of the Spanish guidelines evaluated is very low. The AGREE Instrument in its Spanish version is consistent for the Spanish guidelines and easy to use.

Humans↗

Representation primitives, process models and patient data in computer-interpretable clinical practice guidelines: a literature review of guideline representation models.

Representation of clinical practice guidelines in a computer-interpretable format is a critical issue for guideline development, implementation, and evaluation. We studied 11 types of guideline representation models that can be used to encode guidelines in computer-interpretable formats. We have consistently found in all reviewed models that primitives for representation of actions and decisions are necessary components of a guideline representation model. Patient states and execution states are important concepts that closely relate to each other. Scheduling constraints on representation primitives can be modeled as sequences, concurrences, alternatives, and loops in a guideline's application process. Nesting of guidelines provides multiple views to a guideline with different granularities. Integration of guidelines with electronic medical records can be facilitated by the introduction of a formal model for patient data. Data collection, decision, patient state, and intervention constitute four basic types of primitives in a guideline's logic flow. Decisions clarify our understanding on a patient's clinical state, while interventions lead to the change from one patient state to another.

Artificial Intelligence↗

An analysis of 25 Milliman & Robertson guidelines for surgery: data-driven versus consensus-derived clinical practice guidelines.

SUMMARY BACKGROUND DATA: Managed care guidelines such as those by Milliman & Robertson (M&R) are being implemented with increasing frequency. Many fellows of the American College of Surgeons have raised concerns that the targets set by the M&R guidelines are too aggressive. Uninformed attempts to reach these targets may harm patients. The primary hypothesis of this study was that many of the M&R guidelines are at wide variance from the actual length of stay of patients treated for these diseases. METHODS: Data for the determination of the present practice of care for patients in 25 M&R guidelines were obtained from the hospital discharge data base for North Carolina for 1996. Twenty-five of the M&R guidelines were compared to the actual patient mean, mode, and median length of stay. RESULTS: In 8 of the 25 patient groups, the difference between the actual mean length of stay and M&R guidelines exceeded 5 days. CONCLUSIONS: Many of the M&R guidelines were found to be at wide variance from the actual length of stay of patients treated for these diseases in North Carolina. For many patients, the M&R guidelines are not applicable. Applying them in an uninformed way--in other words, discharging patients from the hospital too early--may hurt some patients. This study should not be interpreted as a criticism of the trend to use guidelines in general; rather, it should be considered a cautionary note that all guidelines must be reviewed scientifically to determine their soundness, applicability, and credibility.

Consensus Statements as Topic↗

[Experiences from practical guideline development--proposal of a more standardized guideline development process].

In this article, the authors of the ,,General Practitioners' Guideline for the Diagnosis and Treatment of Urinary Incontinence" describe the logical and procedural steps involved in the development process of this evidence-based GPs' guideline for the management of urinary incontinence. Specifically, the following factors have been identified as crucial for a successful primary care guideline development process: The work group (authors) should comply in size with current recommendations for successful project work teams. It is recommended that authors should belong to opposing ends of the spectrum of practical versus theoretical medicine. We argue that the integration of both practical experience and theoretical knowledge/research experience be combined in order to collate guideline recommendations that are firmly grounded in scientific evidence and both applicable and acceptable in everyday practice. Proper work on a guideline development project should only start after ensuring that the well-known theoretical requirements for sensible guidelines are met, i.e. the problem in our special focus should be widespread or of considerable economic/public health importance, be amenable to proper medical intervention, and some quality issue regarding the current handling of this problem should have been demonstrated. Subsequently, a clear logical analysis of the problem's inherent functional/logical/practical subdivisions has to be conducted. Each author is then allocated his or her fair share of the work. The next step is considered to be extremely important and consists of discovering one's "illusive correlation", i.e. inherent ideas one has on the subject without being aware of one's own bias. The proposed "trick" now consists of making the implicit bias an explicit fact in the further guideline development process. The remaining work steps build on the integration of one's preformed ideas with current, published opinion from standard textbooks, as well as existing guidelines and non-guideline recommendations on the subject; plus taking into account the practical experience gathered from interviews and "on-location-visits". This integration process is performed within a structured framework to facilitate objectivity and transparency of the entire guideline.

Evidence-Based Medicine↗

[Guidelines for management of epilepsy--commentary on Scottish ("SIGN") guidelines].

The choice of AED (antiepileptic drug), worldwide and in Croatia, is been still based on the physician's subjective decision, personal experience, knowledge and marketing pressure made by big pharmaceutical industries. Therefore, according to some opinions, there is a need of treatment guidelines for epilepsy that would provide relevant information based on scientific evidence on the efficacy, tolerability and safety of AEDs. The guidelines, published by a competent source, should be designed as to allow for easy access to the information on the best practice in specific cases. An extensive background literature review was made to identify such a type of guidelines for the management of epilepsy. The literature review revealed a number of references with the recommendations for treating epilepsy in different groups of patients and from various, specific aspects of epilepsy treatment. However, only one comprehensive set of guidelines for the diagnosis and treatment of epilepsy treatment was found, i.e. the evidence-based guidelines published by the Scottish Intercollegiate Guidelines Network (SIGN). The development of this set of guidelines is quite extensively described in order to illustrate how rigorous and long-lasting the process was, including a great number of health professionals at the national level. Such a type of well designed guidelines facilitates access to highest educational standards for all professionals involved in the primary and secondary care of people with epilepsy. However, it is clear that guidelines can fully replace the standards of clinical practice based on critical evaluation and integration of all clinical data of each individual patient. No guidelines can replace the physician's obligation to keep informed of the novel achievements in the epileptology either.

Epilepsy↗

[The German guideline clearing-project on bronchial asthma - part 2: recommendations and key topics for a national guideline on bronchial asthma].

BACKGROUND: In order to promote the quality of asthma management in Germany, a national asthma guidelines clearing project was initiated in 2000 by the German Guidelines Clearinghouse (Sponsors: German Medical Association (GMA), National Association of the Statutory Health Insurance Physicians (NASHIP), German Hospital Federation, Federal Association of the Statutory Sickness Funds. This Part shows the key topics which should be dealt with in a German guideline on bronchial asthma. SUMMARY POINTS: For quality promotion of bronchial asthma management in Germany, the development of a national evidence-based guideline, using the internationally accepted quality criteria for clinical practice guidelines, was recommended by an expert group of the German Guideline Clearinghouse. The experts identified and peer-reviewed 16 out of 54 guidelines, which might be useful as benchmarks and examples for a German asthma guideline. From the peer review results, the expert group identified 18 key topics for a national asthma guideline.

Asthma↗

Status of practice guidelines in the United States: CDC guidelines as an example.

BACKGROUND: Clinical practice guidelines have proliferated in the past several decades, starting with only a handful in the 1980s to over 1000 approved through The National Guideline Clearinghouse in 2002. METHODS: The purposes of this article to review research related to guideline adoption and impact and to make recommendations for assessing the outcomes of guidelines, using the CDC guideline process as an example. RESULTS: Despite the national movement toward standardization of evidence-based practice, few studies have been conducted to assess the costs of guideline development and implementation, and some practice guidelines have been implemented without concomitant assessment on patient outcomes and costs and benefits of changes in care. CONCLUSIONS: An immediate mandate is to ensure that when guidelines are promulgated, they include an evaluation plan, developed by the implementer of the guideline, which takes advantage of existing qualitative and quantitative data and programs (e.g., patient-centered care, quality assurance, risk management) not limited to expensive and sophisticated clinical trials.

Centers for Disease Control and Prevention, U.S.↗

Consensus guidelines for coordinated outpatient oral anticoagulation therapy management. Anticoagulation Guidelines Task Force.

OBJECTIVE: To provide primary and referring healthcare practitioners with guidelines for the provision of safe and effective anticoagulation management in any venue to standardize and improve quality of care and to permit negotiation for reimbursement from third-party payers. DATA EXTRACTION AND SYNTHESIS: Data on the current practice of anticoagulation providers and outcomes related to anticoagulation clinic care were obtained through the literature, interviews with anticoagulation providers, and a focus group meeting of anticoagulation clinic stakeholders. This information collation process revealed that an anticoagulation service consists of three separate areas for which guidelines should be developed. Based on the consensus opinions of the committee members, the literature review, and the current practice of anticoagulation services providers, a draft guideline was developed and reviewed by an independent multidisciplinary panel of anticoagulation services providers whose comments were incorporated into the final guideline. CONCLUSIONS: Systematic outpatient anticoagulation services are systems of care designed to coordinate and optimize the delivery of anticoagulation therapy by (1) evaluating patient-specific risks and benefits to determine the appropriateness of therapy; (2) facilitating the management of anticoagulation dosages and prescription pick up or delivery; (3) providing ongoing education of the patient and other caregivers about warfarin and the importance of self-care behavior leading to optimal outcomes; (4) providing continuous systematic monitoring of patients, international normalized ratio results, diet, concomitant drug therapy, and disease states; and (5) communicating with other healthcare practitioners involved in the care of the patient. To create a reproducible framework for the provision of these services, guidelines for structure, process, and outcomes of coordinated outpatient anticoagulation management services were developed. Guidelines for organization and management include (1) qualifications for personnel, (2) supervision, (3) care management and coordination, (4) communication and documentation, and (5) laboratory monitoring. Guidelines for the process of patient care include (6) patient selection and assessment, (7) initiation of therapy, (8) maintenance and management of therapy, (9) patient education, and (10) management and triage of therapy-related and unrelated problems. Guidelines for the evaluation of patient outcomes include (11) organizational components and (12) patient outcomes. The impact of these 12 guidelines on patient care and reimbursement procurement will depend on their implementation and the perceived value of their use.

Ambulatory Care↗

Guidelines for guidelines.

Clinical practice guidelines (CPGs) are suited tools for controlling and improving the effectiveness and efficiency of medical care. With the upcoming internet, the numbers of CPGs have increased rapidly, however, only few offer the attributes of good guidelines such as reliability/reproducibility, applicability, flexibility, clarity, multidisciplinary process, scheduled review and documentation of clinical and scientific evidence. Nearly identical criteria for appraisal of CPGs have been developed in many countries consisting of a checklist with questions concerning the quality of development, the content and format, and the applicability of the guideline. In the United States, guidelines which successfully passed the appraisal (or clearing) process, were stored in the National Guideline Clearinghouse, an internet-based database. A German counterpart is under construction, which will comprise clearing reports reviewing and appraising all existent guidelines covering a medical topic. Developing high-quality CPGs is a time consuming and expensive process. A widely accepted guideline for guideline development was published by the Scottish Intercollegiate Guideline Network. CPGs touching neurosurgical topics are rare and often developed without neurosurgical participation. Due to the potential medico-economic impact of CPGs in the future, national neurosurgical societies and their international associations should play a more active role in the development and implementation of CPGs.

Evidence-Based Medicine↗

Hypertension guidelines and their limitations--the impact of physicians' compliance as evaluated by guideline awareness.

OBJECTIVE: The initial step of an optimal therapeutic strategy for patients with arterial hypertension is the recognition and acceptance of new recommendations by the physicians themselves. This guideline awareness of the physicians has never been evaluated in detail. DESIGN: The awareness of content of current recommendations in hypertension diagnosis, treatment and treatment control was therefore assessed in primary care physicians using a questionnaire. The guidelines of the German Hypertension Society were used as the reference standard. PARTICIPANTS: A total of 24 899 German physicians, including all internists, all cardiologists and 22% of general practitioners were contacted in a nationwide survey. MAIN OUTCOME MEASURES: The number of answers in agreement with the guideline was used as a measure of guideline awareness. Adequate awareness of content of guideline recommendations was defined as the correct answer to five out of eight questions; the correct answers had to include the appropriate definition of hypertension. RESULTS: The analysis was based on 11 547 returned questionnaires (47.1%). An adequate guideline awareness was found in 23.7% of the total study population, especially in 37.1% of cardiologists, in 25.6% of internists and in 18.8% of general practitioners. While the guideline awareness was significantly influenced by the duration of private practice, regional and municipal factors had only minor influence on the results. CONCLUSION: The impact of hypertension guidelines on actual medical knowledge is modest. Thus, the information strategies about current treatment guidelines must be improved and tailored to the needs of physicians in clinical practice to ultimately improve patient care.

Awareness↗

Ethnic specific recommendations in clinical practice guidelines: a first exploratory comparison between guidelines from the USA, Canada, the UK, and the Netherlands.

OBJECTIVES: To investigate whether clinical practice guidelines in different countries take ethnic differences between patients into consideration and to assess the scientific foundation of such ethnic specific recommendations. DESIGN: Analysis of the primary care sections of clinical practice guidelines. SETTING: Primary care practice guidelines for type 2 diabetes mellitus, hypertension, and asthma developed in the USA, Canada, the UK, and the Netherlands. MAIN OUTCOME MEASURES: Enumeration of the ethnic specific information and recommendations in the guidelines, and the scientific basis and strength of this evidence. RESULTS: Different guidelines do address ethnic differences between patients, but to a varying extent. The USA guidelines contained the most ethnic specific statements and the Dutch guidelines the least. Most ethnic specific statements were backed by scientific evidence, usually arising from descriptive studies or narrative reviews. CONCLUSION: The attention given to ethnic differences between patients in clinical guidelines varies between countries. Guideline developers should be aware of the potential problems of ignoring differences in ethnicity.

Asthma↗

Bridging the guideline implementation gap: a systematic, document-centered approach to guideline implementation.

OBJECTIVE: A gap exists between the information contained in published clinical practice guidelines and the knowledge and information that are necessary to implement them. This work describes a process to systematize and make explicit the translation of document-based knowledge into workflow-integrated clinical decision support systems. DESIGN: This approach uses the Guideline Elements Model (GEM) to represent the guideline knowledge. Implementation requires a number of steps to translate the knowledge contained in guideline text into a computable format and to integrate the information into clinical workflow. The steps include: (1) selection of a guideline and specific recommendations for implementation, (2) markup of the guideline text, (3) atomization, (4) deabstraction and (5) disambiguation of recommendation concepts, (6) verification of rule set completeness, (7) addition of explanations, (8) building executable statements, (9) specification of origins of decision variables and insertions of recommended actions, (10) definition of action types and selection of associated beneficial services, (11) choice of interface components, and (12) creation of requirement specification. RESULTS: The authors illustrate these component processes using examples drawn from recent experience translating recommendations from the National Heart, Lung, and Blood Institute's guideline on management of chronic asthma into a workflow-integrated decision support system that operates within the Logician electronic health record system. CONCLUSION: Using the guideline document as a knowledge source promotes authentic translation of domain knowledge and reduces the overall complexity of the implementation task. From this framework, we believe that a better understanding of activities involved in guideline implementation will emerge.

Asthma↗

Progress of clinical oncology guidelines development using the Practice Guidelines Development Cycle: the role of practitioner feedback.

PURPOSE: To present an update on the development of oncology practice guidelines (PGs) using the Practice Guidelines Development Cycle (Cycle), and to present the results of surveys of oncologists on the first 10 guidelines from the Cancer Care Ontario Practice Guidelines Initiative. METHODS: Practitioners' opinions about guidelines in development were sought using a mail survey method with systematic follow-up. Practitioners were identified by cancer center representatives. Survey packages included evidence-based recommendations (EBRs) and a one-page, nine-item feedback questionnaire. Data were collected between February 1995 and February 1996. RESULTS: Nine hundred fourteen surveys that pertained to 10 guidelines were mailed to 423 practitioners in Ontario. Practitioners included 112 medical oncologists/hematologists, 34 radiation oncologists, 195 surgeons, and 82 practitioners from other medical specialities. One hundred practitioners were located in cancer centers and 323 had community-based practices. The overall response rate by practitioner was 72% and by survey questionnaire, 70%. For the five questionnaire items that assessed guideline quality, approval ratings ranged from 86% to 92%. For the 10 recommendations, 77% ( 63% to 82%) of respondents agreed that the EBR could be approved as a PG. Response and approval rates were consistent across medical specialities and locations of practice. CONCLUSION: The process of obtaining practitioner feedback in the development of PGs is both feasible and useful. The high response rates to the survey indicate that it is possible to obtain broad participation in evidence-based guidelines development throughout Ontario. The changes made to the EBRs in response to feedback suggest that practitioners' opinions can be valuable in shaping evidence-based guidelines.

Evidence-Based Medicine↗

Diagnostic assessment of nonpalpable breast cancer--the difference in diagnostic approach for the clinical treatment of breast cancer between the Japanese Guidelines and the National Comprehensive Cancer Network(USA)Guidelines.

The detection of non-palpating breast cancer might improve the survival of patients with whole breast cancer because it can be diagnosed at an early stage. Therefore, to standardize the quality of patient care, a published assessment guideline is necessary in a clinical setting. For this purpose, Japan and USA have independent guidelines with different approaches. ''The evidence-based guideline for clinical treatment of breast cancer'' that was published in June 2005 by the Japanese breast cancer society, is the first set of integrated guidelines pertaining to breast cancer in Japan. These guidelines are presented in the research questions (RQ)format. This paper explains 7 RQs(out of 31 RQs)and also discusses the recommendations pertaining to the diagnosis of nonpalpable breast cancer. The National Comprehensive Cancer Network (NCCN; USA)guidelines, which are widely recognized as one of the most reliable guidelines based on published evidences, also contain the diagnostic assessment of asymptomatic patients with a negative physical examination. This paper discusses pros and cons of each of the above mentioned guidelines as well as their clinical application. It is necessary to use both the Japanese and NCCN guidelines while understanding the differences between the two.

Breast Neoplasms↗

[The Japanese new guideline for the management of hypertension--background of its preparation and characteristics of the new guideline].

The Japanese society of hypertension organized guidelines subcommittee for guidelines for the management of hypertension by request of Japanese physicians and people in the Ministry of Health and Welfare in 1998. Professor Masatoshi Fujishima in the School of Medicine, Kyushu University became a chairman in the committee. He had proceeded the preparation smoothly, and in July, 2000 the new guideline for the management of hypertension was published. The Japanese new guideline for the management of hypertension is slightly different from those in other countries, such as JNC-VI or the WHO/ISH guideline. The Japanese new guideline was prepared under the consideration of characteristics of hypertension in Japan, Japanese life style and recent trends in the management of hypertension in Japan. It is desired that Japanese physicians treat hypertensive patients according to this new guideline, and questionable parts in the guideline should be corrected to make it more useful and valuable. Especially the parts peculiar to the Japanese guideline should be ascertained by further studies in Japan.

Antihypertensive Agents↗

Using a clinical practice guideline to measure physician practice: translating a guideline for the management of heart failure.

BACKGROUND: Effective clinical practice guidelines should improve clinical outcomes, and measures of physician use of clinical practice guidelines should correlate with improved outcomes. This study translates a clinical practice guideline on heart failure into review criteria to measure physician performance and the effectiveness of the clinical practice guideline. METHODS: A panel of 11 family physicians and 1 cardiologist systematically reviewed the clinical practice guideline for its clinical importance, educational relevance, and evaluative appropriateness. Then a subset of 4 family physicians rigorously applied each recommendation to established criteria for measurability and developed an evaluation tool useful in medical record review. RESULTS: The heart failure clinical practice guideline was found to be an excellent educational tool. Using it to measure physician performance, however, was limited to diagnostic tests and drug prescribing. Of 45 recommendations, 5 fulfilled criteria for measurability; 1 recommendation had A-level evidence, whereas 2 recommendations had B-level and 2 had C-level evidence. CONCLUSION: This study illustrates the logistic issues and challenges in developing a measure of physician adherence to clinical practice guidelines. Medical record review is inadequate to measure many recommendations. Physicians use of this clinical practice guideline must be evaluated as an intermediate step to measuring the effectiveness of clinical practice guidelines based on patient outcomes.

Evidence-Based Medicine↗

[Guideline report of the Guideline Group of Hessen--general practice therapy circle: management of chronic heart failure].

In this report, the Guideline Group of General Practitioners (GPs) in Hessen (Leitliniengruppe Hessen--Hausärztliche Pharmakotherapiezirkel) describes the motivation and working procedure for developing an evidence-based GPs' guideline for the management of chronic heart failure. Insufficient use of recommended drug therapy and the frequency of probably avoidable hospitalisation are regarded as important deficiencies in the medical care of patients with chronic heart failure. In this report the guideline group demonstrates the identification and interpretation of evidence for their recommendations and suggests indicators for monitoring adherence to the guideline using prescription data. The topics raised in this report follow the checklist of the German Manual for Clinical Practice Guidelines (Germ-CPG) published by the German Association of the Scientific Medical Societies (AWMF) and the German Guideline Clearinghouse. The guidelines have been developed in the context of the pharmacotherapeutic quality assurance program of the Association of Health Insurance Physicians of Hesse (KV Hessen)--a well established program of the KV Hessen and the sickness funds (VdAK/AEV.) The members of the guideline group have been engaged as moderators of quality circles for about 12 years.

Chronic Disease↗